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Acalabrutinib - Generic Drug Details

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What are the generic sources for acalabrutinib and what is the scope of patent protection?

Acalabrutinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib has one hundred and twenty-nine patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for acalabrutinib

International Patents:	129
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	103
Patent Applications:	588
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib
What excipients (inactive ingredients) are in acalabrutinib?	acalabrutinib excipients list
DailyMed Link:	acalabrutinib at DailyMed

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 1/Phase 2
Shin Mineishi	Phase 1/Phase 2
Milton S. Hershey Medical Center	Phase 1/Phase 2

See all acalabrutinib clinical trials

Pharmacology for acalabrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

US Patents and Regulatory Information for acalabrutinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes			Y

International Patents for acalabrutinib

Country	Patent Number	Estimated Expiration
Israel	230511
Mexico	2014000746
European Patent Office	3613745
Eurasian Patent Organization	201992270

Supplementary Protection Certificates for acalabrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	C02734522/01	Switzerland		PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
2734522	PA2021004	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522	LUC00202	Luxembourg		PRODUCT NAME: ACALABRUTINIBOU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522	CA 2021 00007	Denmark		PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106